{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "159653", "product_res_number": "Z-0172-2018", "event_date_initiated": "2017-11-03", "event_date_created": "2017-11-28", "recall_status": "Terminated", "event_date_terminated": "2020-12-14", "res_event_number": "78488", "product_code": "IYE", "k_numbers": [ "K122451" ], "product_description": "BRAINLAB EXACTRAC VERO, Model/Catalog Numbers:\n46228 EXACTRAC VERO 3.5 \n46238 EXACTRAC VERO 3.5 \n46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3\n46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4\n\nThe ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.", "code_info": "Potentially affected are ExacTrac Vero versions 3.x. Currently only ExacTrac Vero SW versions 3.5(.x) are installed for use on existing ExacTrac Vero Systems (only ExacTrac Vero v.3.5 exist in the field). UDI: 04056481132446", "firm_fei_number": "3002619595", "recalling_firm": "Brainlab AG", "address_1": "Olof-Palme-Strasse 9 9 olof-palme-strasse", "city": "Munich", "country": "Germany", "reason_for_recall": "Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.", "root_cause_description": "Software design", "action": "The firm notified their consignees by email on November 3, 2017. \n\n\"Instructions to customers what to do with the recalled product.\n\nFor instructions for the user how to address this issue, and to avoid a patient and treatment target position potentially different than intended due to this issue, please also refer to the User Corrective Action section in the attached\nField Safety Notice / Product Notification letter CAPA-20171011-001985:\n 1. After applying a couch shift always perform a verification image of the patient position before enabling the treatment beam.\n 2. Do not use the Virtual Isocenter function if a verification of the patient position in the treatment isocenter is not feasible.\n\nPlease continue to follow the instructions and warnings as described in the user guide. Especially relevant is the following warning in the Clinical User Guide ExacTrac Vero: Brainlab highly recommends performing an X-ray verification after each change to the couch/Robotics Position.\"\n\nFor further questions, please call 1 (800) 784-7700.", "product_quantity": "28 units", "distribution_pattern": "Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. 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